How well an organization manages its CAPAs is a barometer for how well it manages quality overall. With a well-defined process—and software to help document and coordinate the details—companies can avoid many common CAPA issues that lead to audit findings, quality escapes, and even recalls.
This article looks at 12 strategies for successful CAPA management using a quality management system (QMS), including:
• How to standardize workflows and processes
• CAPA metrics you should be tracking
• Root cause analysis best practices
• The essential role of risk in the CAPA process
1. Establish a closed-loop process
Establishing responsibilities, due dates, escalation rules, and approvals in the QMS creates an accountability loop that prevents CAPAs from slipping through the cracks in the face of more pressing priorities.
6. Address frequent issues first
Audit management: Verifying implementation and the effectiveness of solutions developed as part of the corrective action process is critical. Adding new audit items to check helps close the loop on issues so you can see where further improvements might be needed.
11. Think like an auditor
Document management: Where corrective actions involve updating documentation such as SOPs, processes, or specifications, it’s important to have a direct link to those documents to ensure follow-through.
While major or critical issues may seem like where you need to focus your attention, the frequency of an issue provides the real guidepost in terms of what to prioritize. That’s because even minor issues, if they are occurring frequently, have a bigger cumulative affect on the organization than one-off issues that are major or critical.
Using an automated QMS, manufacturers can create standardized workflows for different types of corrective actions. For example, companies might want to create different CAPA workflows depending on the issue source, such as:
• Customer complaints
• Deviations and nonconformances
• Returns
• EHS incidents
• Supplier problems
There’s no question about it: Should an auditor or inspector visit your facility, one thing that will certainly be under the microscope is your corrective and preventive action (CAPA) system.
This allows for a more consistent process for handling different types of CAPAs efficiently. For instance, certain CAPAs may need to be routed to different individuals or groups, or may call for a specific investigation type.
4. Use the right root cause analysis tool
By thinking like an auditor, companies can better prepare for external audits and inspections while continuously improving their CAPA process as a whole.
12. Document everything
Companies that are successful with CAPA management are adept at monitoring CAPA KPIs and using them to drive continuous improvement. Examples of CAPA KPIs that can be helpful to track include:
• Number of open CAPAs
• Average closure time
• Number of overdue issues
• Number of repeat CAPAs
• Metrics on CAPA aging
• CAPA first-time-through rate
• CAPAs by issue type
10. Link CAPAs to related processes
To avoid compliance problems and strengthen their CAPA processes, manufacturers should look at their CAPA system through the eyes of an external auditor. Your goal should be to proactively identify gaps by asking questions like:
• Which CAPAs have been open the longest and why?
• Are issues and nonconformances such as out-of-spec (OOS) results being thoroughly investigated?
• Where is CAPA documentation lacking?
• Are risk assessments a routine part of the CAPA process?
A large number of overdue corrective actions is a sign that you aren’t effectively managing CAPAs. It’s also something to watch out for from a compliance perspective, because FDA regulators and ISO auditors don’t look kindly on a huge backlog of unresolved problems—and are more likely to scrutinize the rest of your processes if they see this.
Differentiating between classes of issues based on risk can help determine where resources should be directed. Definitions of minor, major, and critical issues might vary from one organization to another; however, many target the following timelines for closure:
• Minor: 30 days
• Major: 45 days
• Critical: 60 days
8. Identify bottlenecks
Manufacturers should look at their CAPA system through the eyes of an external auditor.
Who is responsible for each step? How will you escalate tasks that aren’t completed on time? Where should the completed CAPA be routed for approvals and signatures? What processes do you have in place to review CAPAs as part of your quality management review?
There are two areas companies should focus on: documenting CAPA details and documenting the CAPA process itself.
For corrective actions to be effective, manufacturers need a closed-loop process for ensuring that CAPAs are completed and that implemented solutions work. Best practices and international standards such as ISO 9001 mention the plan-do-check-act approach, which covers steps such as:
• Documenting issues and initial containment actions
• Investigation using the right root cause analysis tools
• Creating the action plan and assigning tasks
• Effectiveness checks and reporting
• Issue follow-up via related processes such as audit management and employee training
2. Incorporate risk assessment into CAPAs
The final strategy presented here is one that’s surprisingly simple, yet often overlooked: CAPA documentation. Lack of or poor CAPA documentation is a frequent cause of FDA 483 observations and warning letters, and thus must be a central point of focus for manufacturers looking to stay compliant.
Being able to filter your corrective actions by risk also provides a more detailed view into your CAPA process. Risk can then be incorporated into your reporting for data-driven decision-making that puts business impact front and center.
3. Standardize CAPA workflows
Being able to filter your corrective actions by risk also provides a more detailed view into your CAPA process.
In the context of the QMS, establishing a truly closed-loop process requires linking your CAPA system to other related QMS solutions, such as:
Creating comprehensive CAPA records is much easier if you’re using an automated QMS, which allows you to document essential elements such as:
• Source data (e.g., from complaints, nonconformances, deviations) to provide context in root cause analysis investigations
• Investigation details and findings
• Risk assessment results
• Action items completed, with FDA-compliant audit trails and electronic signatures
• Effectiveness checks
The frequency of the issue provides the real guidepost in terms of what to prioritize.
And it’s not just compliance that companies need to worry about. The truth is, effective CAPA management is a basic requirement for continuous improvement. Done well, CAPA management can lead to safer, higher quality products that delight customers. Poorly managed corrective actions, on the other hand, can lead to massive recalls, financial penalties, and reputational damage.
Published June 25, 2024, on the AssurX blog.